BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTRIPER EHL UNIT

    MDR report key: 17314 · Received July 21, 1994

    Report

    Report Number
    17314
    Event Type
    Malfunction
    Date Received
    July 21, 1994
    Date of Event
    January 24, 1994
    Report Date
    February 14, 1994
    Manufacturer
    NORTHGATE TECH.
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN USING E.H.L DURING LITHOTRIPSY PROCEDURE. PROBE TIP DESTROYED AND BROKE OFF AND WAS RETRIEVED.NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOTRIPER EHL UNIT EHL UNIT NORTHGATE TECH. SD-100

    Patients

    Seq Age Sex Outcome Treatment
    1 88 * Other